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Wednesday, 5 October 2011

The Sapheon system for treating varicose veins will soon be trialled in Europe.

Sapheon is basically "super-glue" that is put up inside the vein to be treated, using a long thin tube (called a catheter).

This tube can be positioned under ultrasound control making sure it is positioned in the correct position, and then the glue (CyanoAcrylate) injected.

The advantages of this system are that like Endovenous Laser Ablation (EVLA) and Radiofrequency Ablation (RFA) it is put up inside the vein under ultrasound control - so it is done without general anaesthetic through pin-holes only.

A supposed advantage is that "tumescent" anaesthetic doesn't have to be injected around the vein (like the claims by Clarivein - see earlier in this blog) as there is no heat. However whether this is an advantage to the patient or just to the fact that this gets around a US Patent on using tumescence held by another company is less clear!

However before we all rush to use this new technique, there are several questions that need to be answered.

Although the company claims that it closes the vein and causes fibrosis (which is good and what we want) the model on pig veins that is quoted seems to show fibrosis INSIDE the vein - NOT of the whole thickness of the vein wall.

We already know that sclerotherapy when used in the the big "truncal" veins causes fibrosis inside the vein - but not through the whole vein wall, and the failure rate over the first couple of years in unacceptably high.

Therefore, just as our councerns with the medium to long term results from Clarivein for the same reason, we would worry that Sapheon will show good "closure" of the treated veins in the first few months by bunging up the vein with a combination of clot and fibrous tissue - only to have an increasing number of failures over the first few years as the living vein wall always healing and the vein to re-open.

Hopefully for Sapheon they will be able to show this is not the case - but on our current understanding of how venous occlusion works and our own research, we doubt that the results will be anywhere as good as the 100% closure and atrophy of veins we are seeing at 5 - 10 years post EVLA and RFA when used under The Whiteley Protocol(TM)